The Effect of Photobiomodulation on Pressure Ulcers

Ankara Medipol University

Status: Not yet enrolling

Conditions: Pressure Ulcer (PU)

Treatments: Device: photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07307885

university (Registry Identifier)

Ankaramedipol

Details and patient eligibility

About

Photobiomodulation Group (Intervention Group):

Before the intervention, the patient's skin sensitivity to light will be tested by applying light for 3 minutes to one-fourth of the forearm skin. If redness occurs and persists for more than 2 hours, this indicates photosensitivity, and the intervention will not be performed.

The Patient Information Form will be completed during the first meeting with the patients included in the study. Subsequently, blood values will be determined, the Patient Assessment Form will be filled out, vital signs will be measured, and then the intervention will begin. After routine wound care/cleaning procedures in the intensive care unit, without applying any medication, cream, or lotion to the wound area, red light (660 nm wavelength) will be applied to the wound area for 5 minutes at a distance of 55 cm during the first 3 days, and for 10 minutes at the same distance on the following days. This application will continue once daily for 14 days. Wound assessments will be performed, and photographs will be taken on Day 1, Day 4, Day 7, and Day 14 (Baracho et al., 2021; Viecelli et al., 2024; Lima et al., 2020).

Control Group:

The Patient Information Form will be completed during the first meeting with the patients included in the study. Subsequently, blood values will be determined, the Patient Assessment Form will be filled out, and vital signs will be measured. No intervention will be performed other than the routine wound care procedure carried out in the intensive care unit. Wound assessments will be performed, and photographs will be taken on Day 1, Day 4, Day 7, and Day 14, in the same manner as in the intervention group.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with Stage II pressure ulcers
• Patients without any skin disease
• Patients with albumin, platelet, and blood glucose levels within normal ranges
• Patients who will stay in the intensive care unit for 14 days or longer
• Patients with a BMI of 35 or below
• Patients with vital signs within normal limits
• Patients with an oxygen saturation level of 90% or above

Exclusion criteria

• Patients who do not consent to participate in the study
• Patients with severe nutritional problems and those who are cachectic
• Patients with severe edema (+4 or above)
• Patients with diabetes mellitus
• Patients who show photosensitivity in the light sensitivity test
• Patients with metastatic tumors, high fever, thromboangiitis obliterans, vascular insufficiency, active tuberculosis, acute soft tissue infection, pregnancy, bleeding tendency, skin sensory disorders, or skin allergies
• Patients with acute injuries within the past 72 hours
• Patients with a pacemaker, defibrillator, or other electronic implants
• Patients taking medications known to cause photosensitivity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

photobiomodulation group

Experimental group

Description:

photobiomodulation intervention group

Treatment:

Device: photobiomodulation

control group

No Intervention group

Description:

routine hospital care